AVITA BPW-15XX Arm Type Bluetooth Blood Pressure Monitor User Manual 72 B63MN 151

AVITA Corporation Arm Type Bluetooth Blood Pressure Monitor 72 B63MN 151

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BPW 15XX User Manual

Manual

INSTRUCTION MANUALModel No.: BPM63ZBArm Type Bluetooth Blood Pressure MonitorPLEASE READ THIS INSTRUCTION MANUAL COMPLETELY BEFORE OPERATING THIS UNIT.

Index123345681010111213131414141516Intended UseImportant Information Before UseProduct IdentificationDescription of LCD DisplayBattery InstallationSetting the Date and TimePlacement of the Pressure SleeveMeasurement of Pulse Rate and Blood PressureIrregular Heartbeat DetectorWorld Health Organization (WHO)Memory FunctionOperating the Bluetooth functionTroubleshootingError CodesCare and MaintenanceApplied StandardsTechnical SpecificationFCC StatementEMC Tables

Intended Use1BPM63ZB Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate.All values are shown on the LCD monitor.This device is designed only for adults.

2Important Information Before Use1. Blood pressure measurements should only be interpreted by a physician or a trained health care professional who is familiar with your medical history. Through regular use of this device and recording of your measurements, you can keep your physician informed of the changes in your blood pressure.2. Perform your measurement in a quiet place. You should be seated in a relaxed position.3. Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If you are exhibiting signs of stress, avoid taking your measurement until the feeling subsides.4. Rest 15 minutes prior to taking a reading.5. Remove any constrictive clothing or jewelry that may interfere with the cuff placement.6. Keep the monitor stable during measurement to achieve an accurate reading. Remain still; do not talk during the measurement.7. Record your daily blood pressure and pulse readings on a chart.8. Take your readings at the same time, each day or as recommended by your physician to get an accurate indication of change in your true blood pressure.9. Wait a minimum of 15 minutes between readings to allow for the blood vessels to return to normal. The wait time may vary depending on your individual physiological characteristics.10. Although such cases are rare, for those with an extremely weak pulse or irregular pulse, errors may result which prevent proper measurement. If abnormal variations are noticed, consult with your physician or trained healthcare professional.11. This device is intended for adult use. While taking a measurement, you can stop the inflation or deflation process of the cuff at any time by pressing the POWER button.Under any circumstances, the measurement taking result is ONLY for reference.Any further medical action should follow the advice of doctors.

INDEX3Product IdentificationDescription of LCD Display Arm Cuff Air Connector Plug(connects to Air socket) Air tubeDate TimeSystolicPressureDiastolicPressurePulseRateHeartbeatSymbolInflation/Deflation SymbolMemory SymbolMemory SetsLow Battery SymbolAverage Measurement SymbolIrregular Heart Beat SymbolAir Socket(insert Airconnectorplug here)MEMORYRecallButtonLCD DisplaySTART/POWERButton (on/off)Date and TimeSet ButtonWHO Indicator

Battery InstallationLow battery warning:It is necessary to replace the batteries when the Low Battery symbol “ ” appears on the display, or when the display does not turn on after the POWER button is pressed.Replacing the Battery:1. Press down on latch and lift the cover on the bottom of the monitor.NOTE: Battery-operated1. Please properly dispose of the batteries away from small children and heat.2. It is recommended to remove the batteries if the unit will not be used for an extended period of time.3. Batteries must be disposed of in accordance with local environmental and institutional policies.2. Insert or replace 4 x 1.5 V AA batteries into the battery compartment, ensuring to match the indicated polarity symbols. Always use new batteries.3. Replace the battery cover.4

Setting the Date and TimeDateMinute5MonthYearHourIt is necessary to set the date and time for the unit every time batteries are initially installed or replaced.1. While in power off mode, press the “Date and Time Set” button to enter Date and Time setting procedure and the Year value will begin to flash.2. Press the “MEMORY Recall” button to advance the display to the desired year, press “POWER” button to confirm the year.3. Next, the month will blink. Repeat step 2 to set the month and date, then hours, then minutes.4. After setting the minutes, the unit will automatically exit out of the date/time setting mode and briefly show the word OFF before shutting down.Press the“POWER”buttonPress the“POWER”buttonPress the“Date and Time Set”buttonPress the“POWER”buttonPress the“POWER”buttonPress the“POWER”button

It is important to avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If for any reason you are unable to or should not use your left arm, please modify the instructions for cuff application to your right arm. Your physician can help you identify which arm is best for you to take measurements from.1. Remove any constrictive clothing or jewelry that may interfere with cuff placement.2. Be seated at a table or desk with your feet flat on the floor.3. The cuff should not be plugged into the monitor until after the cuff is applied to your arm.Placement of the Pressure SleeveNote:Blood pressure naturally varies from one arm to the other; therefore, measure your blood pressure on the same arm to ensure comparability of the two readings.66. Insert your left arm into the created cuff cylinder. Position the ( ) mark over the main artery on the inside of your arm.Main Artery7. The bottom edge of the cuff should be positioned approximately one inch above the elbow joint.4. Position the cuff on a solid surface with the tubing facing up and away from you. The metal ring/bar on the cuff should be to the left of the tubing.5. Open the cuff by pulling or rolling the bottom of the cuff to the right. This should open the cuff without fully unrolling it, creating a cylinder. Do not fully unwrap or unroll the cuff.

Placement of the Pressure Sleeve8. Reaching underneath your left arm with your right hand, pull the end of the cuff towards your body to tighten the cuff.Wrap and secure the cuff, making sure that the ( ) mark remains in place as shown.9. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger easily between your arm and the cuff.10.The cuff size is suitable for use when the vertical ‘index’ mark is within the horizontal OK range. A different size cuff is needed if the ‘index’ mark is outside the OK range.7Note:If you are not comfortable with applying your cuff, please seek the assistance of another member of your household or work with your physician to practice the cuff application. Incorrectly applied cuffs may result in inaccurate readings.

Measurement of Pulse Rate and Blood PressurePlease read the preceding portions of this manual prior to taking your first reading.1. Position the monitor on a flat, stable surface with the digital display in view.2. Insert the cuff tubing connector into the port on the left side of your monitor.3. Rest your elbow on a solid surface with your palm facing upward. Elevate your arm so that the cuff is at the same level as your heart. Relax your left hand.4. Press the POWER button. This will turn the power on.5. After the self-test, the values for the last reading will appear on the display.6. The blood pressure monitor start to measure.7. The cuff will automatically begin to inflate, with the display showing the increasing pressure in the cuff. As the pressure increases, an arrow pointing up will appear on the display.8. When the inflation has reached optimum level, the display will begin to show the decreasing pressure; the screen will display an arrow pointing down while you feel the pressure of the cuff decrease.8

Measurement of Pulse Rate and Blood Pressure9. To detect the heartbeat, the heartbeat symbol will appear and continuous flashes on the LCD display.12. Your reading will be automatically stored in "MEMORY Recall" Button.13. Select POWER to turn the unit off and conserve energy and battery life. The unit will automatically shut-off approximately 2 minutes.910.Your blood pressure measurement and pulse will display simultaneously on the screen.11.The Hypertension Indicator will indicate your reading range on the display separately.

10Irregular Heartbeat DetectorYour digital blood pressure monitor features an Irregular Heartbeat Detector. This feature allows users to accurately monitor blood pressure even if an irregular heartbeat should occur. When an irregular heartbeat is detected, the “ ” icon will appear on the display.Note:Please consult with your physician or trained healthcare professional for further information regarding an irregular heartbeat and if this symbol appears frequently.World Health Organization (WHO)This unit features our unique Hypertension Indicator. The World Health Organization has established globally accepted standards for the assessment of high or low blood pressure readings. The below chart should be considered only as a guideline, always consult with your physician or health care professional to interpret your individual results.Hypertension IndicatorDiastolic Blood Pressure859010011080130120OptimalNormalHigh-NormalMild Hypertension (Grade 1)Moderate Hypertension (Grade 2)140 160Severe Hypertension (Grade 3)180Systolic Blood Pressure

Memory FunctionYou can recall up to 60 measurements per memory bank, plus an average of last 3 currently stored measurements in memory to share with your physician or trained healthcare professional.From power display off, press and hold down the "MEMORY Recall" Button until the display shows CLr. This indicates that all measurements have been erased.11Recalling Measurements in Memory:3. All results for a given measurement will display, including measurement results, pulse rate, Hypertension Indicator, Irregular Heartbeat alert, and date/time stamp.4. The memory bank stores up to 60 readings; when the number of readings exceeds 60, the oldest data will be replaced with the new record.5. Press the Power button to turn the monitor OFF at any time during review of the stored measurements.Clearing Measurements from Memory:1. Press and release the "MEMORY Recall" Button. The unit will first display the average of last 3 currently stored measurements.2. Continue to press the "MEMORY Recall" Button to successively view the next previously stored measurements. Measurements will appear on the display from most current to oldest; the memory number will appear on the lower left corner.Press the“MEMORY Recall”button

12Operating the Bluetooth functionBPM63ZB is through the Bluetooth technology (BLE4.0) to transfer the related information of your blood pressure measurement. Please determine your device (Mobile Phone or Computer) has BLE4.0 equipped to support BPM63ZB operation. Currently, BPM63ZB can support the iOS and Android operating systems.1. Press “Memory recall button” of blood pressure monitor to enter memory mode. The symbol “AVG” and “M” will appear on the display and the number of memory index is “00”. 2. Turn on the Bluetooth function of device to search the blood pressure monitor. Then the blood pressure monitor will be searched and connected the Bluetooth device.3. After the connection is completed, you can press memory recall button to display the memory result on LCD. Each result showed on LCD, the result will be transmitted by Bluetooth immediately. You can also send results in memory zone as following step.

Care and Maintenance1. Clean the device and arm cuff carefully only with a slightly moistened cloth. 2. Do not immerse the device in water. It may cause damage if water enters.3. Do not use any gas, strong detergent, or solvents to clean the device, including the arm cuff.4. Disconnect the cuff and tubing from the monitor prior to storing.5. Do not use any liquids on the monitor or cuff.6. Use a soft, dry cloth to clean your monitor.7. Do not store in direct sunlight, dust or excessive humidity.8. Avoid extreme temperatures.9. Do not disassemble the monitor or cuff.10.Remove batteries if the monitor will not be used for an extensive period of time.This product conforms to the provisions of the EC di re ctive MDD (93/42/EEC). The following standards apply to design and/or manufac tu re of the products:‧EN 1060-1Non-invasive sphygmomanometers-P ar t1 : General requirements‧EN 1060-3Non-invasive sphygmomanometers-P ar t 3 : Su pplementary requirements for electro-Mechanical blood pressure measurin g system‧EN 1060-4Non-invasive sphygmomanometers - Par t 4: Test procedures to determine the overall system accuracy of automated non-invasive sphyg mo manometers‧ANSI/AAMI Sp10Electronic or automated sphygmomanomet er s．ISO 14971Medical devices-Application of risk ma na gement to medical devices. The Classification according to IEC/EN 60601-1 sub-claues 5 :．Internally powered equipment．IPX0．Equipment not suitable for use in the presen ce o f a fl ammable anaesthetic mixture with air or with oxygen or nitrous oxide．Continuous operation14Applied StandardsTechnical Specification10℃40℃-20℃50℃• Measuring range :• Calibration Accuracy:• Operating environment :o o o o10 C~40 C (50 F~104 F)with relative humidity up to 85% (non condensing)• Storage/ Transportation environment :o o o o-20 C~+50 C (-4 F~+122 F)with relative humidity up to 85% (non condensing)• Power Source :• Weight :• Dimensions :• Cuff circumference (M Size) : approx. 22 ~ 33 cm (9” ~ 13”)Blood Pressure : 30~280 mmHgPulse Rate : 40~199 beats/minBlood Pressure : ± 3 mmHgPulse rate : ± 4% of reading4 x 1.5 V AA batteriesapprox. 275g (exclude batteries)approx. 113mm x 140mm x 57mm (W x H x D)

15FCC StatementNote: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:1. Reorient or relocate the receiving antenna.2. Increase the separation between the equipment and receiver.3. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.4. Consult the dealer or an experienced adio/TV technician for help.5. FCC Caution: To assure continued compliance, (example – use only shielded interface cables when connecting to computer or peripheral devices). Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.6. This device complies with Part 15 of the FCC Rules.Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.7. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be colocated or operating in conjunction with any other antenna or transmitter.

EMC Tables16The BPM63ZB Arm Type Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the BPM63ZB Arm Type Blood Pressure Monitor should assure that it is used in such an environment.Guidance and manufacturer's declaration-electromagnetic emissionsEmissions test Compliance Electromagnetic environment guidanceRF emissionsCISPR 11Group 1 The BPM63ZB Arm Type Blood Pressure Monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissionsCISPR 11Class BThe BPM63ZB Arm Type Blood Pressure Monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2Not applicableVoltage fluctuations/flicker emissionsIEC 61000-3-3Not applicableThe BPM63ZB Arm Type Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the BPM63ZB Arm Type Blood Pressure Monitor should assure that it is used in such an environment.Guidance and manufacturer's declaration-electromagnetic immunityImmunity test IEC 60601 test levelElectromagneticenvironment-guidanceElectrostaticdischarge (ESD)IEC 61000-4-2± 6 kV contact± 8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.Compliance level± 6 kV contact± 8 kV airPower frequency(50/60 Hz)magnetic fieldIEC 61000-4-83 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.3 A/m

17EMC TablesThe BPM63ZB Arm Type Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the BPM63ZB Arm Type Blood Pressure Monitor should assure that it is used in such an environment.Guidance and manufacturer's declaration-electromagnetic immunityImmunity test IEC 60601 test levelElectromagneticenvironment-guidanceRadiated RFIEC 61000-4-33 V/m80 MHz to 2,5 GHzCompliance level3 V/mNOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which the BPM63ZB Arm Type Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the BPM63ZB Arm Type Blood Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BPM63ZB Arm Type Blood Pressure Monitor.b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Portable and mobile RF communications equipment should be used no closer to any part of the BPM63ZB Arm Type Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanced=1.2 √Pd=1.2 √P 80 MHz to 800 MHZd=2.3 √P 800 MHz to 2,5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyª, should be less than the compliance level in each frequency range.Interference may occur in the vicinity of equipment marked with the following symbol:b

EMC TablesThe BPM63ZB Arm Type Blood Pressure Monitor is intended fo use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BPM63ZB Arm Type Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BPM63ZB Arm Type Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment.Recommended separation distances between portable and mobile RF communications equipment and the BPM63ZB Arm Type Blood Pressure MonitorSeparation distance according to frequency of transmittermRated maximumoutput powerof transmitterW150 kHz to 80 MHzd=1.2 P80 MHz to 800 MHzd=1.2 P800 MHz to 2.5 GHzd=2.3 P0.120.01 0.120.380.1 0.381.21 1.23.810 3.812100 120.230.732.37.323For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.18

Manufacturer:AViTA Corporation9F, No.78, Sec.1, Kwang-Fu Rd.,San-Chung District,24158 New Taipei City, TaiwanNo.858, Jiao Tong Road,Wujiang Economic Development ZoneJiangsu Province, P.R.C.Postcode: 215200Made in P.R.C.72-B63MN-151

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